Evaluation of the Effectiveness of a Community Health Management Program for Dry Eye Disease in Middle-Aged and Elderly Individuals

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

• Ages 45 years and older
• All sexes
• No healthy volunteers
• Adult, Older adult

Trial locations and contacts

1 site in 1 country.

About this study

Conditions

Dry Eye Disease

Being tested

Health Management Intervention Program, Standard Treatment

Medical subject headings

Dry Eye Syndromes

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

• Health Management Intervention ProgramProcedure or surgery

  This study implemented a 12-week eye health management intervention program based on the Protection Motivation Theory (PMT). The intervention included eye health interventions conducted twice weekly at community health service locations.During the health management process, specialist doctors from higher-level comprehensive hospitals provided professional guidance, while community general practitioners took on a leading role. They provided personalized eye health management for patients under the guidance of the PMT theory. The intervention content included group education, individual guidance, experience sharing meetings, and traditional Chinese medicine appropriate technology, among other aspects.

• Standard TreatmentProcedure or surgery

  Each week, patients were subjected to standard treatment and follow-up procedures, including basic interventions, medication, and routine follow-up via phone or WeChat, during which general conditions were assessed.

What is being measured

The primary outcome is the main question the study is designed to answer.

1. Goal Attainment Scaling (GAS)

   GAS is an individualized assessment method encompassing multiple personal goals, with a standardized formula for calculating total scores to facilitate comparisons. A score of 50 represents the expected level of achievement, with higher scores indicating greater goal attainment. GAS demonstrates good reliability, validity, and sensitivity. Based on the GAS goal list, researchers and participants collaboratively select goals and assign weights. Expected goals (assigned 0 points) and other goal levels (significantly above expected +2, slightly above expected +1, slightly below expected -1, significantly below expected -2) are established. Goal attainment is evaluated during follow-up, and GAS scores are calculated.

   Measured: 12 weeks

2. Ocular Surface Disease Index (OSDI)

   The OSDI questionnaire assesses common dry eye symptoms and their frequency, aiding in the grading of dry eye severity. It focuses on symptoms such as dryness, foreign body sensation, stinging, photophobia, blurred vision, and the impact on daily life and environmental factors. Symptoms are rated on a scale of frequency: always (4 points), most of the time (3 points), half of the time (2 points), occasionally (1 point), and never (0 points). The OSDI total score is calculated as (sum of item scores × 25)/12, ranging from 0 to 100, with higher scores indicating more severe symptoms.

   Measured: 12 weeks

3. Schirmer I Test

   The Schirmer I test measures tear secretion by placing a Schirmer strip under the lower eyelid conjunctiva with the patient's eyes closed, measuring tear absorption over 5 minutes. This test is widely used to evaluate dry eye syndrome. Tear secretion measured by Schirmer I test (without anesthesia) >5 mm/5 min and ≤10 mm/5 min indicates mild dry eye; >3 mm/5 min and ≤5 mm/5 min indicates moderate dry eye; and ≤3 mm/5 min indicates severe dry eye.

   Measured: 12 weeks

4. Quality of Life for Dry Eye Patients

   NEI-VFQ-25：This is one of the most commonly used ophthalmic quality of life questionnaires, assessing vision-related issues and patients' quality of life. It consists of 25 questions divided into three parts: general health and vision, limitations in activities, and responses to vision problems. The items are categorized into dimensions such as overall health, overall vision, eye pain, near activities, distance activities, peripheral vision, color vision, driving, social functioning, role limitations, dependency, and mental health. Respondents rate their subjective experience on a 5 or 6-point scale, with scores weighted according to the question type, using values such as 100, 75, 50, 25, 0, or not scored. The highest possible score is 100, and the lowest is 0. Scores for each dimension are averaged, and overall scores for each section are averaged from the dimension scores. Higher scores indicate better quality of life.

   8.Diagnostic Criteria for Dry eye disease (DED).

   Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted5 Jun 2024
2. Study start1 Feb 2024
3. Primary completionJan 2025 (estimated)
4. Study completionJan 2025 (estimated)

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Other trials for Dry Eye DiseaseStudies of the same condition, open and under way.
• What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.